Alkermes announced that it has started a Phase 1 study to investigate extended dosing intervals of aripiprazole lauroxil as treatment for schizophrenia.
Aripiprazole lauroxil is an investigational, long-acting injectable atypical antipsychotic being developed as a once-monthly treatment for schizophrenia. Once in the body, the drug converts into aripiprazole, sold commercially as Abilify. Alkermes’ New Drug Application (NDA) for aripiprazole lauroxil once-monthly is currently being reviewed by the U.S. Food and Drug Administration (FDA).
The open label, randomized Phase 1 study will involve around 140 patients with schizophrenia to investigate aripiprazole lauroxil’s pharmacokinetics, safety, and tolerability. The study will assess in particular two new extended durations of the drug: once every six weeks and once every two months. After a 30-day screening period, patients will be randomized to receive either 441 mg once per month, 882 mg every six weeks, or one of two formulations of 1064 mg every two months for six treatment months.
“Our goal is to continue to move the frontier by creating the first long-acting atypical antipsychotic designed to be dosed every six weeks or every two months. …Our aim is to continue to apply our innovative technology to bring forward options for the treatment of schizophrenia,” said Elliot Ehrich, CMO of Alkermes.
Schizophrenia is a severe, chronic, and debilitating brain disorder characterized by positive and negative symptoms, as well as disorganized thinking. Positive symptoms include hallucinations and delusions, while negative symptoms include social withdrawal, depression, and dulled emotions. The disorder affects an estimated 2.4 million adults in the U.S. It is estimated that the disorder develops in one in every 100 people around the world.
The company said it expects results from the Phase 1 study of aripiprazole lauroxil extended dosing in mid 2016. Earlier this year, Alkermes reported positive results from the late-stage study of the drug against placebo as treatment for schizophrenia.